CDC/IDSA COVID-19 Clinician Call - June 5, 2021

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CDC/IDSA COVID-19 Clinician Call - June 5, 2021
CDC/IDSA
COVID-19
Clinician Call
                                                       • 68th in a series of weekly calls, initiated by CDC as a
                                                         forum for information sharing among frontline
                                                         clinicians caring for patients with COVID-19
June 5, 2021
                                                       • The views and opinions expressed here are those
                                                         of the presenters and do not necessarily reflect the
Welcome & Introduction                                   official policy or position of the CDC or
Susanna Visser, DrPH, MS                                 IDSA. Involvement of CDC and IDSA should not be
Senior Advisor, Policy and Partnerships Team             viewed as endorsement of any entity or individual
HSWS Task Force COVID-19 Response                        involved.
Associate Director for Policy & Extramural Program
Division of Vector-Borne Diseases                      • This webinar is being recorded and can be found
National Center for Emerging and Zoonotic Infectious     online at www.idsociety.org/cliniciancalls.
Diseases
Centers for Disease Control and Prevention
                                                                                                                   1
CDC/IDSA COVID-19 Clinician Call - June 5, 2021
Debbie Dowell, MD, MPH, CAPT, USPHS
                         Deputy Chief Medical Officer
                         COVID-19 Response
                         Centers for Disease Control and Prevention

                         Emilia (Emily) Koumans, MD, MPH
                         Clinical Disease and Health Systems Team Lead
                         COVID-19 Response
                         Centers for Disease Control and Prevention

TODAY’S TOPIC:           Lilian Abbo, MD, FIDSA
                         Chief Infection Prevention and Antimicrobial Stewardship
Update on Breakthrough   Jackson Health System
                         Professor of Infectious Diseases
                         University of Miami Miller School of Medicine
Infections
                         Shweta Anjan, MD
                         Assistant Professor of Clinical Medicine
                         Division of Infectious Diseases
                         University of Miami Miller School of Medicine

                         David Andrews, MD
                         Associate Professor of Clinical Pathology
                         University of Miami Miller School of Medicine
                         CLIA Laboratory Director, Jackson Memorial Hospital
                                                                                    2
CDC/IDSA COVID-19 Clinician Call - June 5, 2021
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                                               3
CDC/IDSA COVID-19 Clinician Call - June 5, 2021
CDC Science Brief: COVID-19 Vaccines and Vaccination

Debbie Dowell, MD, MPH
Deputy Chief Medical Officer, COVID-19 Response
CDC/Infectious Diseases Society of America
Clinician Call

June 5, 2021

                                             cdc.gov/coronavirus
CDC/IDSA COVID-19 Clinician Call - June 5, 2021
CDC Science Brief: COVID-19 Vaccines and Vaccination
▪ Available at www.cdc.gov/coronavirus/2019-ncov/science/science-
  briefs/fully-vaccinated-people.html
▪ Purpose: to summarize the evidence supporting CDC’s Interim Public
  Health Recommendations for Fully Vaccinated People
▪ Last updated April 2, 2021
    – Guidance update released April 27
    – Guidance update released May 13
    – Substantial increase in the evidence base
CDC/IDSA COVID-19 Clinician Call - June 5, 2021
Summary of Major Updates to Science Brief
▪ 17 new studies showing effectiveness of COVID-19 vaccination
    – First real-world study of Johnson & Johnson’s Janssen vaccine
▪ 9 new studies supporting reductions in transmission of SARS-CoV-2 by
  vaccinated people who become infected
    – 3 new studies of vaccine effectiveness against asymptomatic infection
    – 4 new studies showing reduced viral load among infected vaccinated people
    – 2 new studies directly documenting reduced transmission
▪ More data on effectiveness of mRNA vaccines against variants of concern
▪ Streamlined content to focus on robust body of vaccine evidence
    – Created separate brief for evidence supporting travel recommendations
CDC/IDSA COVID-19 Clinician Call - June 5, 2021
Summary of Current Evidence (1st of 2 summary slides)

 ▪ Effectiveness of COVID-19 vaccines ≥7 days post-vaccination
     – mRNA vaccines 85%-99% effective against symptomatic disease
          • One study from Denmark estimating 64% effectiveness in long-
            term care residents
     – mRNA vaccines 92%-98% effective against severe disease and 87%-
        97% against hospitalization
     – J&J/Janssen vaccine 77% effective against symptomatic disease
CDC/IDSA COVID-19 Clinician Call - June 5, 2021
Summary of Current Evidence (2nd of 2 summary slides)
 ▪ Effectiveness of COVID-19 vaccines against transmission
     – mRNA vaccines 65%-92% effective against asymptomatic infection
     – Transmission risk to household contacts approximately halved by
        vaccination
 ▪ Effectiveness of COVID-19 vaccines against variants
     – mRNA vaccines: >85% overall when B.1.1.7 prevalent
     – Pfizer-BioNTech: 90% against B.1.1.7; 75% against B.1.351
     – J&J/Janssen: reduced VE when B.1.351 prevalent but ≥73% vs. severe
        disease
CDC/IDSA COVID-19 Clinician Call - June 5, 2021
What We’re Still Learning
▪ Effectiveness of vaccination among immunosuppressed populations
     – Reduced immunogenicity of vaccination observed among several groups
▪ Duration of immunity
▪ Level of population immunity needed for community protection
▪ Real-world effectiveness of Johnson & Johnson’s Janssen vaccine on outcomes
  including severe disease, hospitalization and death.
▪ More about effectiveness against viral transmission and infection with variants
  of concern
CDC/IDSA COVID-19 Clinician Call - June 5, 2021
Key Points
▪ All COVID-19 vaccines currently authorized in the United States are effective against
  COVID-19, including serious outcomes like severe disease, hospitalization, and death.
▪ A growing body of evidence indicates that people fully vaccinated with an mRNA
  vaccine are less likely to have asymptomatic infection or to transmit SARS-CoV-2 to
  others. Studies are underway to learn more about the benefits of Johnson &
  Johnson/Janssen vaccine.
▪ Available evidence suggests the currently authorized mRNA COVID-19 vaccines
  provide protection against a variety of strains, including B.1.1.7 and B.1.351; other
  vaccines show reduced efficacy against B.1.351 but may still protect against severe
  disease.
For more information, contact CDC
1-800-CDC-INFO (232-4636)
TTY: 1-888-232-6348 www.cdc.gov

The findings and conclusions in this report are those of the authors and do not necessarily represent the
official position of the Centers for Disease Control and Prevention.
The Miami Experience at Jackson Health System
     Variants, Vaccinations and COVID-19
           Breakthrough Infections

                     Lilian Abbo, M.D., FIDSA
       Chief Infection Prevention & Antimicrobial Stewardship
                        Jackson Health System
                    Professor of Infectious Diseases
            University of Miami Miller School of Medicine
Disclosure
• No conflicts of interest to disclose
JMH licensed
    1550 beds
   270 ICU beds

2 Community Hospitals

  2 Long Term Care
      Facilities              12,000 employees
                        500 University of Miami Faculty
   4 Miami-Dade
  Corrections/ Jails
What about our Healthcare workers?
                               As of June 3, 2021
                               7401 vaccinated

                              19 vaccine
                              breakthrough
                              cases identified
                              (rate 0.25%)
Case Presentation
• 61-year-old male
• Past Medical history: HTN, Nephrotic Syndrome, ESRD on hemodialysis since 6/2020
• Received 2 doses of mRNA vaccine (Pfizer-BioNTech) 78 days prior

• Presented with fever, cough, dyspnea, nausea, and diarrhea for 3 days
• No prior COVID-19 infection and no severe reactions to the vaccine
• On physical exam: patient was in distress, with decreased breath sounds bilaterally

                                                                                        16
Labs and Imaging

   WBC 19.9
    10(3)/mcL                      D-dimer: 1.57   CRP: 8.2
   ANC: 17.8      Platelets: 235
                                      mcg/ml        mg/dl
    ALC: 1.2

                                                    Blood
 Ferritin: 2094    LDH: 1042        Troponin:
                                                   Cultures:
     ng/ml           unit/L        0.027 ng/ml
                                                   Negative
Hospital Course
    Day of
   Hospital
  admission:                           COVID-19
    78 days                            Antibodies
 from second                            Detected
     dose,
                                       Total: 156              Day 6 – 8,
  On 4 L/min
    of O2                              IgG: 22.18              4-5 L via NC

                 Day 2: Increased O2                Day 3-5,                  Discharged
                 requirements; HFNC                                             Home
                    45/FiO2 100%                    15L NRB
Remdesivir and
dexamethasone
Acknowledgments
• ID Colleagues
Drs Laura Beauchamps, Jovanna Bertran, Foluaskin Ayoade, Stephen Morris, Yoichiro Natori, Jacques Simkins, Shweta Anjan

• University or Miami Pathology/Genetics/Cancer Center Colleagues
Drs. Merce Jorda (Chair), Emmanuel Thomas, Sion Williams (Cancer Center), Yi Zhou, Anthony Griswold (Genetics), Jacob McCauley
(Genetics), Octavio Martinez, Ranjini Valiathan, Ms. Yamina Caratini

• JHS Antimicrobial Stewardship and Pharmacy Teams
Venessa Goodnow, Ennie Cano, Ana Vega, Kailyn Deronde, Meshell Maxam, Christine Vu, Julio Simon, Renata Boatright, Veronica Salazar.

• JHS Infection Prevention Team
Kathleen Sposato, Maribel Ruiz, Adriana Jimenez, Javier Cardozo, Regina McDade, Natalia Fadul, Jolie Dobson, Paula Weisberg, Regina
Williams, Kelley Manzanillo, Christopher Christy, Delia Roberts, Olga Orozco, Doreen Amarsingh

• JHS Microbiology Lab Team
     • Huy Dingh, Biaggio di Pascale, Clara Prado, Sallie Wright, Katiuska Parra, Joanna Danton

• JHS Information and Technology
     • Dr. Alina Brebene, Dr. Joseph Zeitouini, Jermaine Allen, Donna Benjamin
Thank you

  @liliabbo
Updates on COVID-19 Vaccine
breakthrough infections: Clinical
    perspective from Miami

                   Shweta Anjan, MD
       Assistant Professor of Clinical Medicine
           Division of Infectious Diseases
     University of Miami Miller School of Medicine
Disclosure
• No conflicts of interest to disclose
Vaccine breakthrough
                infections

Immunocompetent        Immunocompromised
     N=9                     N=18
Immunocompetent
Demographics                                              Co-morbidities
• Mean Age: 70 years (58 - 89)                            • 67% HTN
• 67% Male                                                • 89% BMI >25
• 78% Hispanic                                            • 22% DM

     Median time from vaccine to COVID diagnosis: 67 days (9-115) (56% mRNA, 44% Ad26.COV2.S)

     All required hospital admission (67% ICU, 33% COVID-19 Ward)

 Management
                                                        Outcomes
 • Remdesivir + dexamethasone 55%
                                                        • 89% recovered and discharged home
 • Convalescent plasma, tocilizumab 11%
                                                        • 11% (n=1) mortality
 • Supportive care 11%
Immunocompromised: Solid organ transplant recipients

• Antibody response lower than general population

• Severe immunosuppression has been linked to Chronic COVID-19 and
  Virus variants

  1. Boyarsky BJ et al. Antibody Response to 2-Dose SARS-CoV-2 mRNA Vaccine Series
     in Solid Organ Transplant Recipients. JAMA. 2021;325(21):2204–2206.
  2. 2. Abbasi J. Researchers Tie Severe Immunosuppression to Chronic COVID-19 and
     Virus Variants. JAMA. 2021;325(20):2033–2035.
Immunocompromised: Solid organ transplant recipients

 • As of April 30, 2021, 2957 SOTR have been vaccinated →18 cases (breakthrough rate
   0.60%)
 • 83% were fully vaccinated

 • Demographics
    • 58 (41 – 81) years
    • 50% Female
    • 72% Hispanic ethnicity

 • 50% →exposed to an unvaccinated family member with COVID-19
TYPE OF ORGAN TRANSPLANT
 Kidney     Liver   Lung   Combined

                                      •   Time from transplant to first dose of the vaccine
          17%                             →26 (range 2 - 90) months
                                           – 3/18 within 6 months of transplant
 5%

                                      •   Time from vaccine to diagnosis →25 days (range, 4
 11%
                                          – 96)
                           67%
Clinical Course

                        Hospital admission                    Outpatient
                               56%                              44%

           Remdesivir 100%
                                                         Casirivimab/Imdevimab
           High dose steroids 90%                                 39%
           Total plasma exchange 30%

                                                         28% admitted within 28 days of receiving MAB
Recovered and        Death          Still hospitalized   for non-COVID-19 care
 discharged
                   10% (n=1)              10%
    home
                                                                All Recovered
    80%
In Summary
• Severe COVID-19 and mortality can occur in vaccine breakthrough cases

• Encourage patients to seek medical care early while they may qualify for MAB

• Immunocompromised individuals should continue wearing a mask

• Vaccine breakthrough data comparing available vaccines (mRNA, viral vector and
  adjuvanted protein platforms) are needed

• Vaccine protocols may need to be tailored by State, population and predominant variant
Questions?

sxa835@med.miami.edu
  @shwetanjan
SARS-CoV-2 gene variant trends from
    patient and student samples
   in Miami-Dade County, Florida
                              David Andrews, MD

                        Associate Professor of Clinical Pathology
                    University of Miami Miller School of Medicine
                Vice-chief, Pathology, Jackson Health System Hospitals
     CLIA Lab Director, Jackson Memorial, Jackson North, Jackson South Hospitals

                                    June 5, 2021
Disclosure
• No conflicts of interest to disclose
Study Design
        Non-HSRO/deidentified samples for Surveillance effort
• Beginning mid-January 2021, residual clinical samples were retrieved
  from the lab after Positive SARS-CoV-2 molecular results obtained.
• Samples initially screened in Pathology by qPCR with the TaqPath
  (TaqPath COVID-19 PCR, Thermo Fisher Scientific) assay to detect the
  B.1.1.7 UK Variant as manifested by the S-Gene target failure (SGTF)
• Sequencing methods developed in our Cancer Center (Sylvester
  Comprehensive Cancer Center) Oncogenomics Core facility, where the
  NEB Biolabs ARTIC method of multiplexed amplicon-based whole viral
  genome sequencing was implemented on the Illumina NovaSeq
  platform. Program overseen by Dr. Sion Williams.
• Bioinformatics pipeline was handled by Dr. Anthony Griswold in our
  UM Genetics Institute (Hussman Institute for Human Genomics)
Sample sources – weekly collections

Jackson Memorial Hospital
Jackson North Medical Center
Jackson South Medical Center
Ambulatory Urgent Care Centers

 UHealth Tower
 (University of Miami Hospital)
 Sylvester Cancer Center          Undergraduate Students
                                  Active SARS-CoV-2
                                  screening program
Overall lineage trends: Varied & Diverse, like Miami!

                                     PANGO Lineages
B.1.1.7 trending down
Increasing prevalence Jan -> May 2021
             Variants of Concern, Variants of Interest, emerging Variants of interest.

                                                                                     B.1.427/29 “CA” VOC

                                                                                  B.1.526 “NY” VOI
                                                                                                                            VOC, VOI,
                                                                                                                            emerging VOI,
                                                                                                                            other than B.1.1.7
                                                                              P.1 “Brazil (Manaus)” VOC

                                                                 B.1.1.7 “UK” VOC

                               March 2021 (N = 138)    April 2021 (N = 162)                            May 2021 (N = 146)
 Feb* 2021 (N = 105)
*includes late Jan samples

                                                                                          PANGO LINEAGE
May 2021 NGS (SARS-Cov-2)

                            May 2021 NGS summary:
                            Approximately
                            88% of samples
                            sequenced revealed
                            a PANGO lineage
                            associated with a
                            VOC, VOI, or
                            an emerging variant
                            of interest.
Feb –> early May VOC/VOI expansion
                                     Conclusion: Despite significant expansion
                                     of VOC/VOI, case numbers are falling in association
                                     with increased vaccination rate. The data
                                     suggests vaccines provide good protection.

 Percent vaccinated
 Miami-Dade County

                                          graphs retrieved 6-4-2021 from
                                                 covidactnow.org
                                     (source data from Florida Dept. of Health)
Quote:
Vaccine evaluations against new variants will be more challenging going forward as data from randomized,
placebo-controlled clinical trials become less common owing to enhanced availability of vaccines.

A global scientific agenda that encompasses extensive genomic surveillance, detailed “correlate of protection”
evaluations, and robust post-introduction surveillance and sequencing is necessary to measure the effect of
new and current vaccines against SARS-CoV-2 variants.

                                                                              NEJM 384;20 May 20, 2021
Thank you!
                dandrews@miami.edu

                                Acknowledgments:
UM: Dr. Merce Jorda (Pathology chair) and Dr. Stephen Nimer (Cancer Center director)
                             JHS: Dr. Peter Paige, CMO
Q&A and Discussion

                     43
Links and Resources
▪ Slide 5 - CDC Science Brief: COVID-19 Vaccines and Vaccinationwww.cdc.gov/coronavirus/2019-ncov/science/science-briefs/fully-
  vaccinated-people.html
▪ Slide 37 – Calculator https://www.medcalc.org/calc/comparison_of_proportions.php

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